Deformable orthosis

ABSTRACT

Hand, knee and elbow orthosis each have a deformable semi-rigid stiffener having two end plates joined by a narrow midportion and contained between thin foam sheets to make an insert. A finger separator may be attached and adjustably positioned on the hand orthosis. The finger separator may include a plurality of upstanding partitions and an elastic element for releasably securing the separator to the orthosis.

This application is a division of application Ser. No. 08/622,478, filedon Mar. 26, 1996, now U.S. Pat. No. 5,733,249.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to orthopedic appliances and in particular todeformable splints for application to the elbow, hand or knee of a humanpatient to achieve a gradual, controlled extension of the limb to whichit is applied.

2. State of the Prior Art

Persons debilitated by old age or chronic illness, particularly thosebound to a wheelchair or bedridden, develop a tendency to retract theirlimbs to a persistently contracted condition. The arm, leg and hand areall susceptible to this affliction.

An accepted treatment for this condition is for a physical therapist toexercise the affected limb by flexing the pertinent joint through therange of motion possible under the circumstances, and applying lightforce to extend the limb slightly beyond the existing range of motion.The exercised limb is then fixed at the maximum achieved extension bymeans of an orthosis, or splint, which bridges the joint being exercisedand prevents its retraction. This procedure is repeated duringsuccessive therapy sessions, over a period of weeks, to achieve aprogressive extension of the limb. The orthosis is adjusted followingeach session to prevent the limb from retracting beyond the maximumextension gained during the particular session.

The nearest pertinent prior art is believed to be described in U.S. Pat.No. 5,248,292 issued to Holland, which discloses a static orthosis foruse similar to the orthosis of this invention. Briefly, the Hollandorthosis consists of a deformable unitary body having two pads connectedby a spine. The unitary body is made up of an aluminum endoskeletonwhich is deformable by means of sufficient manual force and retains adesired shape when so deformed. The endoskeleton is molded in a closedcell polyethylene foam matrix. A unitary cover has pockets connected bya spine strap. Each pocket receives one of the end pads of the unitarybody. A number of straps on the cover serve to attach the cover and theunitary body to the limb of the patient.

The Holland device suffers from a number of shortcomings. The removablecover does not entirely enclose the deformable unitary body, leavingexposed portions of the unitary body including edges which can pressinto the skin and tissues of the patient. This requires that the foammatrix around the aluminum endoskeleton provide cushioning. The exposedunitary body comes into contact with the patient and therefore must beperiodically washed and cleaned, since the splint is worn for extendedperiods of time, often several weeks. The straps used to secure thesplint to the patient's limb are attached directly to the unitary body,and are separate from the cover. Removal and reinstallation of thestraps is needed for washing, adding complexity to the use of the deviceand exposing the straps to possible misplacement and loss.

Improved deformable static orthoses are needed featuring greater comfortand ease of use and maintenance.

SUMMARY OF THE INVENTION

The present invention addresses the aforementioned need by providing animproved orthosis for application to a joint of an anatomical limb. Theimproved orthosis has an insert with a semi-rigid stiffener deformableby application of manual force, the stiffener having first and secondend plates joined to each other by a narrower intermediate strip, andopposing sheets of pliable material bonded to each other and defining acontour of the insert, such that the stiffener is completely containedbetween the opposing sheets. A removable cover of launderable fibermaterial is generally fitted to the contour of the insert. The cover hasan interior accessible through a zippered opening for receiving theinsert, so that the insert is fully enclosed and covered by theremovable cover. A number of retaining straps are spaced apart on thecover and extend transversely to the intermediate strip of the insertfor encircling the limb to which the orthosis is applied.

The stiffener is preferably metallic, such as of a soft steel, and theend plates are more readily deformable than the intermediate strip. Theend plates may be of sheet metal such as a mild steel and theintermediate strip is desirably of thicker metal than the end plates.The end plates may be portions of a single metallic sheet whichintegrally includes a narrower mid-portion defining the intermediatestrip, and the intermediate strip includes a reinforcing strip securedfor increasing the stiffness of the mid-portion. The reinforcing stripmay be narrower than the mid-portion, and the reinforcing strip may bewelded to the mid-portion with welding material applied to define atapered transition in thickness between the combined thickness of thereinforcing strip and the midportion, and the thickness of midportionalone. Alternatively, the end plates may be discrete metallic plates andthe intermediate strip a metallic strip of greater stiffness than thediscrete metallic plates.

The opposing sheets of the insert are desirably adhered directly to themetallic stiffener, and the opposing sheets may be of uniform thicknessand foamed synthetic material. The outer covering is preferably made ofterry-cloth material, which can be provided with compressible paddingextending over at least one side of the insert, so that the opposingsheet do not need to provide significant cushioning. The covering mayhave two opposite sides, the zippered opening being on one of theopposite sides, and the other of the opposite sides being padded withcushioning material. The zippered opening preferably extendssubstantially the entire length of the cover in the direction of theintermediate strip. The insert preferably has a longitudinal axis alongthe intermediate strip and each of the end plates and the contourdefined by the opposing sheets is symmetrical about the longitudinalaxis, such that the orthosis is ambidextrous for application to either aright hand or a left hand limb.

Each of the retaining straps may have hook and loop fasteners forsecuring each of the straps in encircling relationship with the limb towhich the orthosis is applied. Each of said retaining straps may have anouter covering and an interior strip of compressible but non-stretchablepadding material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top perspective view of a hand splint according to thisinvention, shown in an initial planar configuration;

FIG. 2 is an exploded view of the hand splint of FIG. 1, showing thebottom side of the cover unzipped for access to its interior and thedeformable insert in position for placement in the cover;

FIG. 3A shows a first type of construction of the metallic stiffener ofthe deformable insert; and

FIG. 3B shows a second type of construction of the metallic stiffener ofthe deformable insert;

FIG. 4 is a sectional view of the assembled splint taken along line 4—4in FIG. 1;

FIG. 5 shows the bottom side of the cover zipped closed;

FIG. 6 is a view as in FIG. 1 showing the hand splint bent to a typicaloperative configuration;

FIG. 6A is perspective view of the deformable insert of the hand splintbent to the operative configuration of FIG. 6;

FIG. 7 is a right side view of the hand splint of FIG. 6 applied to thehand of a patient;

FIG. 8 is a left side view of the hand splint of FIG. 7;

FIG. 9 is a perspective view of a finger separator accessory for usewith the hand splint of FIGS. 1 through 8;

FIG. 10 illustrates typical installation and use of the finger separatorof FIG. 9 with the hand splint applied as in FIG. 7;

FIG. 11 shows an elbow splint according to this invention, applied tothe elbow of a patient;

FIG. 12 is a perspective view of the proximal side of an elbow or kneesplint, bent to a typical shape for application to the elbow of apatient as in FIG. 11 or a knee as in FIG. 14;

FIG. 13 a shows the insert and cover of an elbow or knee splint, inoriginal planar condition; and

FIG. 14 illustrates application of the knee splint according to thisinvention to the knee of a typical patient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to the accompanying drawings, FIG. 1 shows a deformablestatic orthosis or splint, generally designated by the numeral 10, whichby way of example is a hand splint adapted for application to the hand,wrist and forearm of a human patient. FIGS. 2 through 9 furtherillustrate the hand orthosis. The invention is not, however, limited tohand orthosis and the improvements described herein are equallyapplicable to elbow and knee splints, such as are shown in FIGS. 11through 14.

The hand splint 10 in FIG. 1 has two pads, including a front pad 12 anda rear pad 14, which are joined by a narrower waist section 16, arrangedalong a longitudinal axis which traverses all three portions of thesplint. The splint further has a proximal side 18 which is appliedagainst the limb of the patient, and an opposite, distal side 20, seenin FIGS. 4, 5 and 6, which faces away from the same limb.

Turning to FIG. 2, it is seen that the orthosis 10 includes an exteriorcover 22 and a deformable inner 24. The cover 22 has a zippered opening25 on the distal side 20 of the splint 10 which extends nearly theentire length of the cover. Three retaining straps 26 a, 26 b and 26 ceach have one end attached to the distal side of the cover at spacedapart locations along the length of the cover.

The deformable inner 24 is made up of a stiffener 28, seen in phantomlining in FIG. 2, which is entirely contained or laminated between tworelatively thin opposing sheets 30 of foamed synthetic material, asshown in FIG. 7. The stiffener 28 has two end plates, front end plate 32and rear end plate 34, joined to each other by a narrower midportion 36.FIGS. 3A and 3B show alternate forms of the stiffener 28. In FIG. 3A theend plates 32, 34 and the midportion 36 are portions of a single plate40 of uniform thickness. A reinforcing strip 42 is affixedlongitudinally along the midportion 36. The plate 40 and strip 42 are ofa mild steel and the plate is such that it can be bent by moderatemanual force. The reinforcing strip is chosen to substantially increasethe stiffness of the plate 40 along its midportion 36. The result isthat the end plates can be bent in a direction transverse to the lengthof the stiffener with less effort than required to bend the stiffeneralong its midportion. A similar result is obtained in the stiffener 28′of FIG. 3B where separate end plates 32′, 34′ are connected by aconnecting strip 44 of heavier gauge than the end plate material.

In the insert of FIG. 3A the reinforcing strip is welded to the plate 40with a substantially continuous bead of solder or weldment material 45extending about the four sides of the strip 42. The bead 45 is appliedso as to form a tapering transition between the greater thickness of thereinforcing strip and the thickness of the plate 40 around the strip.The tapering transition of bead 45 eliminates a sharp edge around thestrip 42 which might press against the skin of the user even through thelayers of a foam sheet 30 and the cover 22 and be injurious oruncomfortable to the patient.

The foamed sheets 30 are oversized with respect to the stiffener 28 anddefine a contour of the inner 24 which generally follows the contour ofthe stiffener 28, so as to define two end pads, front end pad 46 andrear end pad 48 connected by a narrower intermediate portion 50. Thefront end pad 46 has side wings 52 extending in opposite directionstransversely to the longitudinal dimension of the inner 24,corresponding to wings 49 on the front plate 32 and 32′ of thestiffener. The cover 22 is made of launderable and moisture absorbentterry-cloth fabric, preferably of natural cotton fiber, which entirelycovers and contains the deformable inner 24. The cover 22 generallyconforms to the perimeter and both sides of the inner 24. The inner 24is inserted through the zippered opening 24 so that the front end pad 46fits into the front pad 12 of the cover and the rear end pad 48 fitsinto the rear pad 14 of the cover. The midportion of the inner iscontained by the waist portion 18 of the cover. The assembled splint 10,with the inner 24 inserted into the cover 22 and the zippered opening 24closed, is seen in FIG. 5.

The inner 24 is in an initially planar condition as shown in FIG. 2, andis fitted to a particular patient by bending in both longitudinal andtransverse directions, as suggested in FIG. 6A, to the contour of thelimb to which it is to be applied. The inner 24 retains the shape towhich it is formed and imparts a similar shape to the cover as in FIG.6. Fitting of the splint 10 is normally done with the inner 24 containedinside the cover 22. Typically the proximal side 18 of the splint 10will have a concave curvature at the end pads 12, 14 in a transversedirection and a convex curvature along the waist portion 16 in alongitudinal direction of the splint.

The hand splint 10 is applied as shown in FIGS. 7 and 8. The proximalside 18 of the splint is applied against the underside of the patient'sarm A such that the front end pad 12 supports the fingers of the hand,the rear end pad 14 lies against the forearm, and the waist 16 liesunder the wrist. The splint 10 is secured to the arm A in this positionby wrapping each of the three retaining straps 26 a-c around the forearmand hand and securing the free end of each strap to the distal side 20of the cover by means of mating hook and loop fasteners 54, 56. Astherapy progresses, the curvature of the waist portion 18 is graduallyreduced to achieve extension of the hand and wrist from an initiallyretracted condition. The materials of which stiffener 28 is constructedare chose so that the stiffener, and consequently the splint 10, can beformed to the desired shape by deliberate manual force applied by atherapist, but yet will resist forces to which it is normally subjectedwhen worn by a patient. Neither the opposing sheets 30 nor the cover 22contribute materially to the stiffness, i.e. resistance to deformation,of the splint 10.

The terry cloth cover 22 of splint 10 is padded on the proximal side 18by a layer of compressible synthetic foam 58 contained between a outersheet 60 of terry cloth cover material and an inner liner 62 which isalso of similar terry cloth fabric. The three layers 60, 58, 62 extendover the entire proximal side 18 of the cover and are sewn togetheralong the perimeter 64 of the cover. The foam padding 58 cushionscontact of the patient's arm against the relatively firm inner 24, andparticularly contact against the edges of the opposing foam sheets 30which if unprotected would tend to cause some discomfort to the patientwhen firmly applied against the limb for extended periods of time.

Each of the retaining straps 26 a-c are made of the same terry-clothfabric as the cover 22, and is padded with a strip of resilientcompressible non-stretchable synthetic foam which extends substantiallythe entire length of the strap and is entirely wrapped and covered bythe terry-cloth fabric. The terry-cloth covering of retaining strap 26 ais partially broken away in FIG. 6 to illustrate the foam strip 27. Thefoam strip is made non-stretchable by virtue of a mesh 29 of inelasticfiber bonded to one longitudinal surface of the strip. Such foammaterial is a commercially available product. The same padding isprovided in each of the straps 26 b and 26 c. The padded retainingstraps further reduce the likelihood of injury or discomfort to thepatient when the splint is properly applied by a skilled therapist.

It will be appreciated that the cover 22 and retaining straps 26 a-c arepermanently secured together as a unit which can be easily separatedfrom the inner 24 and washed, cleaned or laundered without concern withseparation or loss of the straps apart from the cover. The syntheticfoam surfaces of the inner 24 can also be easily cleaned or sanitized bymethods appropriate to synthetic foam materials apart from the textilefabric of the cover 22. After cleaning the cover and inner are assembledquickly and easily, as already described.

The side wings 52 of the inner 24 extend into corresponding lateralextensions 15 formed in the cover 22, which are typically bent upwardsfrom the proximal side 18 of the splint, as best understood from FIGS. 6and 6A. The side wings 52 are deformed to the desired position whileinside the cover 22, as in FIG. 6. The inner 24 is shown outside thecover in FIG. 6A for purposes of explanation only. The lateralextensions 15 constitute thumb extenders which serve to separate andextend the patient's thumb T away from the fingers F, as best understoodby reference to FIG. 8. The position of the thumb extenders 15 can begradually adjusted during the course of therapy to achieve gradualextension of the thumb.

The hand orthosis 10 is bilaterally symmetrical about a longitudinalaxis dividing the front, rear and midportion of the splint. Thissymmetry makes the splint 10 ambidextrous, i.e., permits the hand splintto be applied equally to the right or the left hand of a patient, andeliminates the need to purchase and maintain stocks of separate rightand left hand orthoses, with consequent reduction in administrativecosts and improved efficiency of health care institutions where suchsplints are used. In particular, each splint has a left and a right sidethumb extender 15, symmetrically disposed about the imaginarylongitudinal axis, only one of which is used for a particular hand ofthe patient.

FIG. 9 shows an accessory finger separator 70 for use with the handsplint 10. The finger separator 70 has an upper portion 72 of terrycloth fabric folded and sewn to make three upright partitions 74. Theopposite ends of the terry cloth upper are connected by an elastic band76. The separator 70 is fitted onto the splint so as to encircle thefront pad 12, as depicted in FIG. 9, such that the terry cloth upperportion 72 extends across the proximal side of the front pad and theelastic band 76 is stretched over the distal side of the front pad. Theseparator 70 is held on the splint 10 by elastic tension of the band 76.The fingers F of the patient are spaced from each other by the threepartitions 74, each partition being inserted between each pair ofadjacent fingers. Separation of the fingers is desirable in some casesto prevent deformations, ulcerations and other disease processes of theskin and joints when a patient's fingers are pressed together forextended periods of time.

The separator 70 is typically positioned forwardly of the thumbextenders 15 and forwardly of the front retaining strap 26 c. However,the actual position of the separator 70 on the splint is easilyadjusted, forwardly and backwardly as well as side to side, on the frontpad 12, for optimum positioning as required by the shape, size andcondition of the individual patient's hand. The ability to install orentirely remove the finger separator 70 on a hand splint 10 gives thetherapist flexibility during the course of therapy while minimizing thecost of providing a finger separator when needed on an existing handsplint.

FIGS. 12 and 13 show a splint 80 which is shaped for use as an elbow orknee splint. The construction of splint 80 is similar to that of thehand splint 10 explained above, in that splint 80 also has a deformableinner contained and fully enclosed in a terry cloth cover, and numeralsin FIGS. 11 through 14 designate features denoted by like numerals inFIGS. 1 through 8. The elbow and knee splint 80 differs from hand splint10 in that no thumb extenders are needed nor provided, and the two endplates of splint 80 are similar to each other, so that splint 80 is notonly bilaterally symmetrical about a longitudinal axis but alsosymmetrical about a line transverse to the waist of the splint. Thecentral retaining strap 26 b is bifurcated at 82 to wrap on either sideof the elbow E or knee K, as shown in FIGS. 11 and 14 respectively. Thesplint 80 is made in different sizes, a smaller size for application tothe elbow and a larger size for the knee. The difference between theelbow and knee splints is however one of scale only. In FIG. 13 thecover 22 is shown open along its zippered opening 24 and the deformablestiffener is shown in its initial flat, planar condition and removedfrom the cover. In FIG. 12 the splint 80 is shown assembled and formedto a shape appropriate for application to a knee or elbow of a patient.

The several advantages and improvements described in connection with thehand splint are equally featured in the elbow and knee splint 80,including provision of padding integral to the removable cover andpermanent attachment of the retaining straps to the same cover. Theconstruction of the inner is similar as is the construction of thestiffener of the inner.

While a preferred embodiment of the invention has been described andillustrated for purposes of clarity and example, it should be understoodthat many changes, substitutions and modifications to the describedembodiment will be apparent to those possessed of ordinary skill in theart in light of the foregoing disclosure without thereby departing fromthe scope and spirit of the present invention which is defined by thefollowing claims.

What is claimed is:
 1. An orthosis for a hand comprising: an inserthaving a semi-rigid stiffener deformable by application of manual force,said stiffener having first and second end plates joined to each otherby a narrower intermediate portion, said stiffener being laminatedbetween opposing sheets of pliable material bonded to each other anddefining a contour of said insert, said stiffener being completelycontained between said opposing sheets; a removable cover of launderablefabric generally fitted to said contour, said cover having an interioraccessible through a zippered opening for receiving said insert, and azipper attached to said cover for selectively opening and closing saidopening, said insert being fully covered by said removable cover in anassembled condition of said orthosis; a plurality of straps attached tosaid cover and adapted for encircling the limb to which the orthosis isto be applied; and a finger separator attachable over said cover in anadjustable position, said finger separator having an upper portiondefining a plurality of partitions and an elastic element for releasablysecuring said upper portion to said cover such that said partitionsextend between adjacent fingers of a hand to which said orthosis isattached.
 2. The orthosis of claim 1 wherein said elastic element is anelastic band connecting opposite ends of said upper portion so as toencircle a portion of said orthosis.
 3. The orthosis of claim 1 whereinsaid upper portion is made of terry-cloth fabric folded and sewn to makesaid partitions.
 4. In an orthopedic hand splint having opposite endportions joined by an intermediate portion configured to apply to ahand, forearm and wrist respectively of a patient, said splint having astrap adapted to encircle said hand for securing said hand splint to thehand, forearm and wrist, the improvement comprising a finger separatorattachment defining a plurality of upstanding partitions, saidattachment being adjustably positionable on one of said end portions,said attachment being configured to separate adjacent fingers from eachother when said hand splint is applied to the said hand, said strap alsoserving to capture the fingers between said partitions in a securedcondition of the splint onto the said hand.
 5. The hand splint of claim4, attachment comprising an upper portion of launderable fabric foldedand sewn to define said plurality of partitions and an underside free ofsaid partitions, and a fastener permanently secured to said upperportion and adapted for adjustably manually removably positioning andreleasably securing said underside without use of tooling to said handsplint such that said partitions extend between adjacent fingers of ahand to which the hand splint is attached.
 6. The hand splint of claim 5wherein said fastener is an elastic element.
 7. The hand splint of claim5, wherein said finger separator attachment comprises three saidpartitions.
 8. The hand splint of claim 5 wherein said partitions andsaid upper portion are defined by a continuous folded strip and whereinsaid strip has opposite ends and said fastener comprises an elasticelement joining said opposite ends on said underside such that saidpartitions face away from said elastic element.
 9. The hand splint ofclaim 5 wherein said launderable fabric of said upper portion is terrycloth.
 10. The hand splint of claim 4 wherein said partitions are onsaid finger separator attachment removably attached to one of said endportions.
 11. A method of ensuring finger separation when applying anorthopedic hand splint having a plurality of retaining straps adapted toencircle the forearm, wrist and hand of a patient, comprising the stepsof selectively positioning and attaching a finger separator attachmenthaving a plurality of partitions upstanding on said splint, securing thefinger separator with an elastic band stretched about the hand splint,applying the hand splint to the said forearm, wrist and hand such thatthe partitions extend between adjacent fingers of the hand, and wrappingone of said straps about the hand and generally over the splint therebyto capture the fingers between the partitions.